A great deal of attention has recently been given to the unacceptable rate of avoidable patient injuries, or so-called medical mistakes, in the United States. Estimates of the number of medical mistakes per year in the United States is difficult to ascertain, but a recent publication, To Err is Human, by Dr. Lucian Leape, suggests that the avoidable death rate for medical mistakes are between 48,000 and 96,000 patients per year.
As defined by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), wrong-site surgery includes wrong side or site of the body, wrong procedure, and wrong-patient surgeries.
Prevalence of Wrong-Site Surgery
From January 1995 to March 2001, JCAHO reviewed voluntary reports of 1,152 “sentinel events.” Wrong-site surgery accounted for 114 cases (9.9%) and included procedures in neurosurgery, urology, orthopedics, and vascular surgery. Despite the high profile of JCAHO's Sentinel Event Policy, under-reporting by healthcare organizations likely affects these statistics. Only 66% of the 1,152 total events were “self-reported” by the institutions involved; the balance coming from patient complaints or media stories. Using a mandatory reporting system, the New York State Department of Health received 46 reports of wrong-site surgery from Apr. 1, 1998 through Mar. 31, 2000, compared with 114 cases JCAHO received nationally over a period 3 times longer. This suggests that voluntary incident reporting may grossly underestimate the true incidence of wrong-site surgery by a factor of 20 or more.
The Physician's Insurance Association of America (PIAA) reviewed the claims data from 22 malpractice carriers representing 110,000 physicians from 1985 to 1995. There were 331 cases of wrong-site surgery. The complete PIAA database documents almost 1,000 closed malpractice claims involving wrong-site surgery. However, this figure also likely underestimates the prevalence of wrong-site surgery. Since most wrong-site surgeries involve relatively minor procedures (arthroscopy, rather than limb amputations or major neurosurgical procedures), sequelae are minimal and may not result in a claim. Consequently, estimates of the incidence of wrong-site surgery derived from litigation data likely underestimate the true prevalence of this problem, as do estimates based on incident reports.
Factors Identified as Contributing to Wrong-Site Surgery
Several factors have been identified that may contribute to an increased risk of wrong-site surgery. These risk factors include:                More than one surgeon involved in the case, either because multiple procedures were contemplated or because the care of the patient was transferred to another surgeon;        Multiple procedures were conducted on the same patient during a single trip to the operating room, especially when the procedures were on different sides of the patient;        Unusual time pressures related to an unusual start time or pressure to speed up the preoperative procedures; and        Unusual patient characteristics such as physical deformity or massive obesity that might alter the usual process for equipment set-up or positioning of the patient.        
The root causes identified by hospitals were most often related to communication, preoperative assessment of the patient, and the procedures used to verify the operative site. Communication issues fall into two major categories:                Failure to engage the patient (or family, when appropriate) in the process of identifying the correct surgical site, either during the informed consent process or by the physical act of marking the intended surgical site; and        Incomplete or inaccurate communication among members of the surgical team, often through exclusion of certain members of the team (e.g., surgical technicians) from participation in the site verification process, or through reliance solely on the surgeon for determining the correct operative site.        
The completeness of the preoperative assessment of the patient was a frequent contributing factor, often through failure to review the medical record or imaging studies in the immediate preoperative period. The procedures for verifying the correct operative site were found to be flawed in many cases due to:                No formal procedure;        No final check in the operating room;        The absence of any oral communication in the verification procedure;        All relevant information sources not available in the operating room;        No checklist to ensure all relevant information sources were checked;        Some members of the surgical team were excluded from the verification process and felt they were not permitted to point out a possible error; and        Total reliance on the surgeon for verifying the surgical site.JCAHO Strategies for Reducing Wrong-Site Surgery        
The Joint Commission offers the following possible strategies for reducing the risk of wrong-site surgery:                Clearly mark the operative site and involve the patient in the marking process to enhance the reliability of the process;        Require an oral verification of the correct site in the operating room by each member of the surgical team;        Develop a verification checklist that includes all documents referencing the intended operative procedure and site, including the medical record, X-rays and other imaging studies and their direct observation of the marked operative site on the patient;        Personal involvement of the surgeon in obtaining informed consent;        Ensure through ongoing monitoring that verification procedures are followed for high-risk procedures; and        “Time out” immediately before starting the procedure. (Source: Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert, issue six, Aug. 28, 1998.)        
Despite the implementation of strategies to prevent wrong patient, wrong site, wrong side surgery, regrettably this seemingly most preventable of complications still occurs. (The aforementioned statistics do not address the number of times in which implants or instrumentation is going to be placed as a part of the procedure, and are not available when the surgeon is ready for them. In these instances, the surgeon must either change plans, or wait while the surgical team attempts to locate the appropriate implants or instrumentation, which, in some instances, is located at another hospital.) The incorrect assumption of a medical professional's infallibility, coupled with organized medicine's focus on the individual's medical mistakes rather than a systems approach have contributed to this problem. In an attempt to improve patient safety, “[e]ffective Jul. 1, 2004, compliance with the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery will be required of all Joint Commission accredited organizations.” As a part of the universal protocol, a “pause” or “time out” is required. This serves as a final verification of: (1) the correct patient; (2) the correct procedure, site and side; and as applicable, (3) the availability of implants or instrumentation, prior to making incision. This is a time when all members of the surgical team are supposed to pause to review the case, and agree that the correct procedure is being done on the correct patient, at the correct site, and on the correct side. In theory, this would ensure that any errors that had been made could be detected prior to incision. In reality, the “time out” seldom occurs; and when it does, not in any uniform or regular manner. Without a uniform or regular procedure, ritualized compliance, i.e. going through the motions results in many institutions. The universal protocol cannot enforce a pause and does not specify a protocol as to what should happen during a pause. The universal protocol does not specify a particular time for the pause to occur, and it does not specify a protocol as to what should happen during the pause, that is to say, what information should be communicated by whom, and to whom. While guidelines may be suggested, each institution determines how to comply, therefore standardization is not achieved.
Accordingly, it can be seen that a need exists for improvements to surgical procedures and devices to prevent or at least reduce wrong-site surgeries. It is to the provision of meeting these and other needs that the present invention is primarily directed.